BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 9363607 · Received November 22, 2019

    Report

    Report Number
    2210968-2019-90214
    Event Type
    Injury
    Date Received
    November 22, 2019
    Report Date
    November 5, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. NOTE: EVENT OF ANASTOMOTIC LEAK WITH INTERVENTION PROLENE SUTURE CAPTURED IN 2210968-2019-90213. CITATION: J HEPATOBILIARY PANCREAT SURG (2005); 12:243¿248. DOI: 10.1007/S00534-004-0961-0. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: LAPAROSCOPIC TREATMENT OF RECURRENT PYOGENIC CHOLANGITIS". AUTHOR : CHUNG-NGAI TANG, CHI-KIN TAI, WING-TAI SIU, JOE P.Y. HA, KA-KIN TSUI, AND MICHAEL K.W. LI. CITATION: J HEPATOBILIARY PANCREAT SURG (2005); 12:243¿248. DOI: 10.1007/S00534-004-0961-0. THE AUTHORS REVIEWED THE SELECTIVE USE OF HAND-ASSISTED LAPAROSCOPIC SEGMENTECTOMY (HALS) AND LAPAROSCOPIC CHOLEDOCHODUODENOSTOMY (LCD) IN THE MANAGEMENT OF RECURRENT PYOGENIC CHOLANGITIS (RPC). THIS RETROSPECTIVE REVIEW OF A PROSPECTIVELY MAINTAINED DATABASE INVOLVES A TOTAL OF 33 LAPAROSCOPIC PROCEDURES PERFORMED IN 30 PATIENTS (7 MALE AND 23 FEMALE; MEAN AGE: 63.2±14.9 YEARS; AGE RANGE: 29¿92 YEARS) WITH RPC DURING THE PERIOD 1995¿2004. OF THESE 33 PROCEDURES, THERE WERE 23 LCDS AND 10 HALS. THREE PATIENTS UNDERWENT BOTH LCD AND HALS IN THE SAME OPERATION. DURING LAPAROSCOPIC CHOLEDOCHODUODENOSTOMY (LCD), A SIDE-TO-SIDE FULL THICKNESS ONE-LAYERED CHOLEDOCHODUODENOSTOMY (CD) ANASTOMOSIS WAS PERFORMED. THE POSTERIOR ROW WAS SUTURED INTERRUPTEDLY, USING 2/0 MONOCRYL (ETHICON). THE FIRST STITCH WAS TAKEN TO APPROXIMATE THE LOWER END OF THE CHOLEDOCHOTOMY AND THE MIDPOINT OF THE DUODENOTOMY. THE KNOT WAS TIED AT THE INNER SIDE OF THE ANASTOMOSIS FOR THE POSTERIOR ROW. TWO STITCHES WERE THEN PLACED AT CORNERS FOR RETRACTION. THE ANTERIOR ROW WAS FINISHED WITH CONTINUOUS STITCHES, USING THE SAME SUTURE, AND THE LAST STITCH WAS TIED AT THE MEDIAL CORNER OF THE ANASTOMOSIS. DURING HAND-ASSISTED LAPAROSCOPIC SEGMENTECTOMY (HALS), MOBILIZATION OF THE ATROPHIC STONE-HARBORING SEGMENT WAS CARRIED OUT USING A HARMONIC SCALPEL (ULTRACISION; ETHICON) AND THE ¿LAPAROSCOPIC HAND.¿ MOBILIZATION WAS ACHIEVED BY DIVIDING THE LEFT TRIANGULAR LIGAMENT AND DETACHING IT FROM THE DIAPHRAGM UNTIL THE LEFT HEPATIC VEIN WAS IDENTIFIED. ONCE THE PRINGLE MANEUVER HAD BEEN APPLIED AND THE CENTRAL VENOUS PRESSURE WAS KEPT BELOW 5CM H2O, THE PARENCHYMAL TRANSECTION WAS CARRIED OUT, USING AN ULTRASONIC SURGICAL AND THE HARMONIC SCALPEL (ETHICON), WHILE THE ¿LAPAROSCOPIC HAND¿ WAS GRASPING THE REMAINING LIVER. THE HARMONIC SCALPEL (ULTRACISION; ETHICON) WAS INDISPENSABLE FOR LIVER RESECTION, AS IT COULD EFFECTIVELY SEAL OFF SMALL VESSELS AND BILE DUCT WITH MINIMAL FOGGING. TOWARD THE END, THE DILATED BILE DUCT WAS CLOSED WITH CONTINUOUS 2/0 PROLENE (ETHICON), USING THE ¿LAPAROSCOPIC HAND¿ TO TIE THE KNOT. REPORTED COMPLICATIONS IN THE LCD GROUP INCLUDED INTRAABDOMINAL COLLECTION (N-?), AND BILE LEAKS (N-?) WHICH WERE ALL MANAGED SUCCESSFULLY, CONSERVATIVELY, WITHOUT REOPERATION, 1 PATIENT IN WHICH THE BILE LEAK WAS COLLECTED IN THE LEFT PLEURAL CAVITY RECOVERED UPON COMBINED PERCUTANEOUS AND ENDOSCOPIC DRAINAGE, REPORTED COMPLICATIONS IN THE HALS GROUP INCLUDED BILE LEAKS (N-?) WHICH WERE ALL MANAGED SUCCESSFULLY, CONSERVATIVELY, WITHOUT REOPERATION, 1 PATIENT IN WHICH THE BILE LEAK WAS COLLECTED IN THE LEFT PLEURAL CAVITY RECOVERED UPON COMBINED PERCUTANEOUS AND ENDOSCOPIC DRAINAGE, INTRAABDOMINAL COLLECTION (N-?), AND BLOOD LOSS RANGE: 100¿1000 ML (N-?). IN CONCLUSION, BOTH LCD AND HALS ARE SAFE, FEASIBLE, AND EFFECTIVE TREATMENTS FOR PATIENTS WITH RPC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156081 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention